The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monoject Soft Tissue Biopsy Needle.
| Device ID | K834249 |
| 510k Number | K834249 |
| Device Name: | MONOJECT SOFT TISSUE BIOPSY NEEDLE |
| Classification | Biopsy Needle |
| Applicant | SHERWOOD MEDICAL CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-07 |
| Decision Date | 1984-03-12 |